Table 1.
Study population A. Patient selection Zero points if patients are not selected on a validated biological/molecular basis; 10 points if they are B. Trial size 2 points if total number of patients is <30; 6 points if >30 or <50; 10 points if >50 |
Analysis and measurement of biological effect C. Study design Zero points if not reported; 10 points if yes D. Biological endpoints Zero points if not reported; 10 points if evaluations of biological endpoints are planned |
Modality of response and toxicity reporting E. Response Zero points if criteria for response assessment are not reported; 10 points if yes F. Toxicity Zero points if criteria for toxicity evaluation are not reported; 10 points if yes |
Modality of preclinical evidence and data reporting G. PERI Zero points if preclinical evidence is not cited; 2 points if PEI<15; 8 points if PEI>15 H. Sites of disease Zero points if not reported; 8 points if reported I. Compliance with treatment Zero points if not reported; 8 points if reported J. Time-to-event descriptions Eight points if overall-survival and/or disease-free survival are reported K. Follow-up Eight points if any information about follow-up is reported (duration, lost to follow-up) |